Urethral implant

Abstract

To provide a novel urethral implant.SOLUTION: The urethral implant comprises at least two struts, an anchor, and at least one drug dispensing wire. The at least two struts extend longitudinally between a proximal end and a distal end of the urethral implant. Each of the struts is flexible between a compressed configuration that enables delivery of the urethral implant to a stricture in the urethra, and an expanded configuration that facilitates expansion of the stricture. The anchor extends outwardly from at least one of the proximal and distal ends for anchoring the urethral implant. At least one drug dispensing wire is adjoined to and extends longitudinally along at least one of the struts, and incorporates a drug to be released into the urethra.SELECTED DRAWING: Figure 1A

Description

[Technical field]

[0001] The disclosed technology relates to urethral implants. [Background technology]

[0002] Urethral implants are generally known in the art. There is a category of urethral implants that are implanted in the male urethra and are used to treat benign prostatic hyperplasia (BPH). BPH is a medical condition also known as prostatic hyperplasia, in which the prostate gland becomes enlarged, leading to a variety of medical problems, such as urination problems (e.g., weak urine flow, loss of bladder control, delayed or prolonged urination, increased frequency of urination), as well as more serious conditions that may result in lower urinary tract infections (LUTS), bladder stones, kidney and / or bladder damage, etc. A variety of treatment options have been proposed and utilized over the years, including oral medications (e.g., alpha-blockers), invasive surgical procedures (e.g., transurethral resection of the prostate (TURP), transurethral incision of the prostate (TUIP)), as well as minimally invasive treatments (e.g., prostatic stent insertion, transurethral microwave thermotherapy (TUMT), transurethral needle ablation (TUNA), transurethral electrovaporation (TUVP)), holmium laser enucleation of the prostate (HoLEP), etc. Each treatment technique has its own advantages and disadvantages.

[0003] One category of such techniques employs the use of urethral implant devices such as those disclosed in U.S. Pat. No. 9,848,905 to Kilemnik, entitled "Radial Cutter Implant," which is directed to a urinary tract dilation method and implant for creating incisions in the tissue surrounding the patient's bladder neck and urethra.

[0004] According to one embodiment, the implant includes four wires, a fixed leaflet, a distal end, and a proximal end. Each wire is bonded between a proximal end and a distal end. The fixed leaflet extends from the distal end and is disposed between two wires. The wires are wider at the proximal end than at the distal end, which prevents the implant from migrating from the bladder neck into the urethra when implanted. The fixed leaflet prevents the implant from migrating from the bladder neck into the bladder.

[0005] The method includes inducing infarction by applying continuous radial pressure to the urethral wall and / or tissue surrounding the urethral wall. The method includes the steps of delving a (detachable) implant near at least one of the bladder neck and the prostatic urethra, releasing the removable implant, and applying continuous pressure with the removable implant. The removable implant has at least one collapsible wire and a self-expandable fastener. When the implant is released, both the collapsible wire and the fastener expand, preventing the implant from moving along the urethral wall in the direction of the bladder. The applied continuous pressure creates a longitudinal incision in the urethral wall and tissue surrounding the urethral wall, radially outward from the urethral axis. When a predetermined condition occurs, the removable implant is removed.

[0006] U.S. Patent No. 11,304,724 to Kilemnik, entitled "Incising Implant for the Prostatic Urethra," is directed to an incising implant for forming an incision in a subject's prostatic urethra. The implant includes at least two closed-shaped wires and a fastener. Each wire has a proximal portion, a distal portion, and two longitudinal portions extending between the proximal and distal portions. Each closed-shaped wire is elastic and thereby compressible from an expanded configuration to a compressed configuration. The longitudinal portions of each wire are joined along their length with another longitudinal portion of one of the wires. In the expanded configuration, the incising implant is configured to incise tissue within the prostatic urethra. The at least two wires flare out at their distal portions such that in the expanded configuration, the distal portions form a simple closed curve shape at the termination of the incising implant. The fastener is closed-shaped and in the expanded configuration extends outwardly from the proximal portion through one of the closed-shaped wires. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] U.S. Pat. No. 9,848,905 [Patent Document 2] U.S. Pat. No. 11,304,724 Summary of the Invention [Problem to be solved by the invention]

[0008] It is an object of the present invention to provide a novel urethral implant. [Means for solving the problem]

[0009] The objective of the disclosed technology is to provide a novel urethral implant. The urethral implant includes at least two struts, a fastener, and at least one drug delivery wire. The at least two struts extend longitudinally between a proximal end and a distal end of the urethral implant. Each strut is flexible between a compressed configuration and an expanded configuration. The compressed configuration allows the urethral implant to be delivered to a stricture in the urethra.

[0010] The expanded configuration facilitates dilation of the stricture. The fastener extends outwardly from at least one of the proximal and distal ends. The fastener is for anchoring the urethral implant within the urethra. At least one drug delivery wire is joined to at least one of the struts and extends longitudinally along the strut. The drug delivery wire incorporates a drug for release into the urethra.

[0011] According to the disclosed technology, a urethral implant is provided. The urethral implant includes three closed-shape wires, a fastener, and at least one drug delivery wire. The three closed-shape wires are flexible between a compressed configuration that allows the urethral implant to be delivered to a stricture in the urethra and an expanded configuration that facilitates dilation of the stricture. Each closed-shape wire includes two longitudinal portions extending between a proximal end and a distal end of the urethral implant. Each longitudinal portion of the closed-shape wire is joined along its length to another longitudinal portion of another closed-shape wire. The closed-shape wires are configured to engage and dilate urethral tissue at the stricture of the urethra. The fastener is for fixing the urethral implant to the urethra. The at least one drug delivery wire is joined to at least one of the closed-shape wires and extends longitudinally along the closed-shape wire. The drug delivery wires are loaded with a drug for release into the urethra.

[0012] The disclosed technology will be more fully understood and appreciated from the following detailed description taken in conjunction with the drawings in which: [Brief description of the drawings]

[0013] [Figure 1A]1 is a schematic illustration of a urethral implant shown in an expanded configuration, constructed and operative in accordance with one embodiment of the disclosed technology. [Figure 1B] 1B is a schematic diagram of the urethral implant of FIG. 1A including a proximal cap, constructed and operative in accordance with one embodiment of the disclosed technology. [Figure 1C] 1C is the urethral implant of FIG. 1B in a compressed configuration, constructed and operative in accordance with one embodiment of the disclosed technology. [Diagram 2] 1 is a schematic illustration of a urethral implant having twisted wires shown in an expanded configuration, constructed and operative in accordance with another embodiment of the disclosed technology. [Figure 3A] 1 is a schematic illustration of a urethral implant shown in an expanded configuration, constructed and operative in accordance with a further embodiment of the disclosed technology; [Figure 3B] 3B is a schematic diagram of the urethral implant of FIG. 3A including a proximal cap, constructed and operative in accordance with one embodiment of the disclosed technology. [Figure 3C] 3C is a schematic diagram of the urethral implant of FIG. 3B shown from distal / proximal direction A, constructed and operative in accordance with an embodiment of the disclosed technology. [Figure 4] FIG. 1 is a schematic illustration of a urethral implant having multiple discontinuous drug delivery wires, constructed and operative in accordance with another embodiment of the disclosed technology. [Diagram 5] FIG. 13 is a schematic illustration of a urethral implant having a drug delivery wire coupled to a closed-shape wire including a fastener, constructed and operative in accordance with a further embodiment of the disclosed technology. [Figure 6A] 1 is a schematic diagram of one configuration of a drug delivery wire constructed and operative in accordance with an embodiment of the disclosed technology; [Figure 6B] 1 is a schematic diagram of another configuration of a drug delivery wire constructed and operative in accordance with an embodiment of the disclosed technology; [Figure 6C] 1 is a schematic diagram of yet another configuration of a drug delivery wire constructed and operative in accordance with an embodiment of the disclosed technology; [Figure 6D]1 is a schematic diagram of yet another configuration of a drug delivery wire constructed and operative in accordance with an embodiment of the disclosed technology; DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0014] The disclosed technology overcomes the deficiencies of the prior art by providing an implant for the urethra of a subject (i.e., patient, person, implantee) (herein "urethral implant"), the urethral implant including at least two struts, a fastener, and at least one drug delivery wire. The at least two struts can be a single wire structure (e.g., closed loop). The urethral implant includes a proximal end, a distal end, and a central portion (middle portion) disposed between the proximal and distal ends. The struts extend longitudinally between the proximal and distal ends of the urethral implant. The struts are flexible between a compressed configuration that allows the urethral implant to be delivered to a stricture (i.e., narrowing, constriction) of the urethra, and an expanded configuration that facilitates dilation of the urethral passageway in general, and the stricture in particular. The fastener extends outwardly from at least one of the proximal and distal ends and is configured and operative to secure the urethral implant within the urethra of the subject. The drug delivery wire is joined to at least one of the struts and extends longitudinally along the struts. The drug delivery wire is loaded with a drug for release into the subject's urethra. The at least two struts are made of a single continuous wire that forms a closed shape. Alternatively, the at least two struts are separate entities that are joined together to form a continuous wire.

[0015] The struts generally provide the urethral implant with a mechanical structural framework that allows it to compress and expand. The drug delivery wire generally provides the therapeutic action of the drug to the target tissue (e.g., stricture) in the urethra. The urethral implants of the disclosed technology provide a synergistic effect between the mechanical action of the wire (strut) and the therapeutic action of the drug delivery wire that extends along the engagement region between the wire and tissue (i.e., the region where the wire (strut) contacts the tissue within the target urethra).

[0016] Specifically, the wires (struts) mechanically engage and apply pressure to the urethral tissue at the engagement area between the wires and the tissue, and at the same time, the drug delivery wires contact the same urethral tissues as the wires (struts) and deliver drug to those tissues (i.e., targeted drug delivery).

[0017] The urethral implants of the disclosed technology are configured and operative to self-expand by using a shape memory alloy (SMA) material, such as nickel titanium (NiTi) (also known by the trade name "Nitinol" (Nickel Titanium Naval Ordinance Laboratories)), that has a memorized expanded and compressed configuration. The urethral implant structure is generally hollow, allowing urine to pass (i.e., through the void) when the urethral implant is implanted in the subject's urethra in an expanded configuration. The urethral implants of the disclosed technology can incise tissue, specifically the wire is configured to apply continuous (ischemic) pressure to the tissue of the urethra (e.g., the prostatic urethra), thereby forming an incision (i.e., the longitudinal struts or wires form corresponding longitudinal incisions), which can result in infarction or tissue necrosis, thus reshaping and expanding the urethra so that urine can flow more easily for the subject suffering from BPH. Additionally, the wire can include at least one jagged edge (e.g., along the length of the wire, or at least partially along the length of the wire) to further facilitate making the incision. In alternative configurations in which the urethral implant does not incise urethral tissue, the urethral implant does not include a jagged edge.

[0018] Urethral implants are generally removable from the subject (via a removal mechanism). Note that all urethral implants disclosed herein are non-vascular implants, i.e., implanted not in a blood vessel through which blood flows, but rather in the urethra through which urine flows.

[0019] Reference is now made to Figures 1A, 1B and 1C. Figure 1A is a schematic illustration of a urethral implant, generally designated 100, shown in an expanded configuration, constructed and operative in accordance with an embodiment of the disclosed technology. Figure 1B is a schematic illustration of the urethral implant of Figure 1A including a proximal cap, constructed and operative in accordance with an embodiment of the disclosed technology. Figure 1C is the urethral implant of Figure 1B in a compressed configuration, constructed and operative in accordance with an embodiment of the disclosed technology. The urethral implant 100 includes a tissue engaging wire 102 (interchangeably referred to herein as "wire"), a tissue engaging fastener 104 (interchangeably referred to herein as "fastener"), and a drug delivery wire 106.

[0020] The wire 102 includes two struts 102A and 102B that extend longitudinally generally along the longitudinal axis 101L of the urethral implant 100 along a proximal portion 110A (interchangeably referred to herein as the "proximal end"), a central portion 110B (interchangeably referred to herein as the "middle portion"), and a distal portion 110C (interchangeably referred to herein as the "distal end"). The two struts 102A and 102B shown in FIGS. 1A and 1B are continuous, i.e., made of a single piece of wire that converges at the proximal end 110A. Alternatively, the struts 102A and 102B are separate pieces (not shown) that are mechanically joined together at the distal end 110C and converge at the proximal end 110A. The central portion 110B is defined to be between the proximal end 110A and the distal end 110C. The length of the central portion 110B along the longitudinal axis 101L is generally greater than the combined length of the proximal portion 110A and the distal portion 110C. 1 and width W 1 (Strut width W 2 ) and a length L 2 and width W 31A and 1B show that the struts 102A and 102B of the wire 102 are geometrically symmetric about the longitudinal axis 101L (same geometric properties such as equal length, width and curvature) and materially identical (e.g., made of the same material and have the same mechanical properties such as elasticity, strength, malleability, resilience, etc.). In a possible alternative configuration (not shown), the struts 102A and 102B are geometrically asymmetric about the longitudinal axis 101L (e.g., at least one of their length, width, curvature or other geometric properties differ from each other) or materially different (i.e., the struts are not made of the exact same material or have different mechanical properties such as flexibility, strength, etc.). The wire 102 is made of a medical grade biocompatible material, such as titanium, gold, stainless steel, or metal alloys such as nickel titanium (Nitinol), tantalum alloys, etc. According to an alternative configuration, the wire 102 is made of a polymer (e.g., a shape memory polymer).

[0021] 1A and 1B show the urethral implant 100 in an expanded configuration. FIG. 1C shows the urethral implant 100 in a compressed configuration. When implanted in a subject, the urethral implant 100 readily expands a stricture in the subject's urethra by exerting pressure on the surrounding tissue. In this regard, the urethral implant 100 generally functions as a compressible and expandable mechanical spring with intermediate compression states between two extremes (i.e., between a fully expanded configuration and a fully compressed configuration). The main structural members of the urethral implant, i.e., struts 102A and 102B, are flexible between a compressed configuration (shown in FIG. 1C) and an expanded configuration (shown in FIG. 1A and FIG. 1B), which allows the urethral implant 100 to be delivered to a stricture in the urethra. 1C, the sheath 114 is configured and operable to encase the urethral implant 100 in a compressed configuration, thereby enabling the urethral implant 100 to be delivered within a subject's body via a delivery device (not shown) to a desired anatomical location within the urethra, typically toward a stricture, where the urethral implant 100 is deployed by releasing it from the sheath 114, thereby self-expanding to the expanded configuration shown in FIGURES 1A and 1B. The sheath 114 is typically a hollow tube (e.g., cylindrical and medical grade) configured to cover, encapsulate, encase, and compress the urethral implant 100 in the compressed configuration.

[0022] The anchor 104 is typically a continuous wire structure including two sides embodied as two struts 104A and 104B, which extend outwardly from a proximal end 110A to a central portion 110B on one side of the longitudinal axis 101L (i.e., in a proximal to distal direction) of the urethral implant 100. The struts 104A and 104B of the anchor 104 are generally made from a single continuous piece of wire that converges at the proximal end 110A. Alternatively, the struts 104A and 104B are separate pieces (not shown) that are mechanically joined together at an apex (i.e., the apex of the anchor 104). The anchor 104 is flexible between an expanded configuration (FIGS. 1A and 1B) and a compressed configuration (FIG. 1C). The anchor 104 has the ability to self-expand to an expanded configuration upon release from the sheath 114. The fastener 104 is generally arcuate with an internal hole and two struts 104A and 104B defining a symmetric closed shape (e.g., a closed loop). Alternatively, the fastener 104 is asymmetric. The fastener 104 is constructed and operative to engage and attach (anchor) to the urethral tissue of a subject in an expanded configuration. The fastener 104 can be detached from the tissue when the urethral implant 100 is removed from the subject. The fastener 104 is made of the same material as the wire 102. Alternatively, the fastener 104 is not made of the exact same material as the wire 102. Typically, the wire that makes up the fastener 104 is thinner than the wire that makes up the wire 102, as shown in Figures 1A and 1B. Alternatively, the wire that makes up the fastener 104 and the wire 102 are the same thickness (not shown). Other alternative configurations of the fastener 104 are possible (e.g., a closed polygon, etc.) (not shown).

[0023] The width of expansion of the urethral implant 100 in the urethra is subject-specific (i.e., dependent on anatomical and stricture-dependent factors (e.g., stricture dimensions, stricture tissue characteristics, etc.)). According to an alternative embodiment, there are multiple fasteners (not shown), such as a second fastener, extending outwardly from the distal end 110C to the central portion 110B on the other side of the urethral implant 100 relative to the longitudinal axis 101L (i.e., a different side than the extension of the first fastener). Further alternatively, two fasteners (not shown) are constructed and operable to extend from the same end (i.e., either the proximal end 110A or the distal end 110C) in opposite directions (i.e., either a distal-proximal direction defined from the distal end 110C to the proximal end 110A, or a proximal-distal direction defined from the proximal end 110A to the distal end 110C).

[0024] The drug delivery wire 106 is joined (bonded) (e.g., continuously wrapped) to the wire 102 along the length of the struts 102A and 102B, beginning and ending at the proximal end 110A (i.e., both ends of the drug delivery wire 106 end at the proximal end 110A). Both ends of the drug delivery wire 106 may be open or closed. Both ends of the drug delivery wire 106 contact each other to define a closed shape. The drug delivery wire 106 is joined to the struts 102A and 102B by helical winding along its entire length (as shown in Figures 1A and 1B). An alternative bond configuration between the drug delivery wire 106 and the closed shape wire 102 is a parallel bond (both wires run parallel to each other, i.e., non-helical (not shown)). The drug delivery wire 106 has a longer overall length than the wire 102. The drug delivery wire 106 incorporates a drug that is delivered (i.e., released, administered) into the urethra when the urethral implant 100 is implanted into a subject. A drug comprises a chemical that is configured to produce or exert a biological effect on a subject. Examples of drugs (pharmaceuticals) include sirolimus (rapamycin) and everolimus. Drugs may be formulated to include time-release mechanisms (e.g., liposomes), also known as modified release dosing, which generally function to deliver (e.g., controlled, sustained, delayed, extended release) a drug that dissolves, diffuses (or both) at a controlled rate over a period of time (i.e., gradually, rather than an "immediate release" formulation). The drug may be coated (fully or partially) onto the drug delivery wire 106.

[0025] 1B and 1C, the proximal end 110A of the urethral implant 100 includes a proximal cap 112 that covers the ends (terminus) of the wires 102, the ends of the anchor 104 wires, and the end of the drug delivery wire 106. The proximal cap 112 is typically made of a medical grade plastic material (such as polyethylene, which does not substantially degrade in the body).

[0026] Prior to dissolution of the drug in the body after implantation, the drug distribution wire 106 has a larger surface contact area (i.e., implant-to-tissue engagement surface area) compared to the wire 102. Once the drug distribution wire 106 is implanted, the drug is configured to dissolve gradually at a controlled rate according to its characteristic time-release drug profile. The drug distribution wire 106 is made of a single strand or multiple strands of a material (e.g., fiber such as cotton fiber, synthetic fiber such as polyester, etc.) that can absorb and exude the incorporated drug when the urethral implant 100 is implanted. Additionally or alternatively, the drug distribution wire 106 is made of a biodegradable material that dissolves when implanted in the urethra of the implant recipient. According to this alternative, both the incorporated drug and the drug distribution wire 106 dissolve over time (e.g., at the same or different rates). The drug distribution wire 106 is compressible between a compressed configuration and an expanded configuration of the urethral implant 100.

[0027] Alternative configurations (not shown) of the drug distribution wire 106 include being joined (e.g., helically wrapped) to only one of the struts 102A and 102B. Another alternative configuration includes having multiple drug distribution wires, each wire incorporating a different drug or the same drug. In the case of at least two different drug distribution wires, each wire is incorporated with a different drug having a different time release profile. Alternatively, the two drug distribution wires can incorporate the same drug but with different time release profiles (linear, non-linear, burst, etc.). The different drug distribution wires may also be constructed of different materials. When the at least two drug distribution wires are intertwined with the struts, there may be multiple intersections between the at least two drug distribution wires. These intersections may or may not have knots. Another alternative configuration may be an integer N>2 drug distribution wires are intertwined or intertwined around the struts, where they form an N-braid pattern. This N-braid pattern can be permuted the same (or differently) for each of the struts and can be twisted in the same direction (or differently). An exemplary 3-ply braid configuration is described below in connection with FIG. 6B.

[0028] When the urethral implant 100 is delivered to a stricture in the subject's urethra (e.g., a stricture in the prostatic urethra), the urethral implant 100 expands to an expanded configuration, which is configured to apply continuous pressure to the surrounding tissue of the urethra at the stricture, thereby expanding the stricture (e.g., reshaping and expanding the bladder neck and prostatic urethra). The fastener 104 expands to the expanded configuration and secures the urethral implant 100 in place by engaging the surrounding tissue of the urethra. The fastener 104 renders the urethral implant 100 relatively immobile (thus avoiding unintended movement into the subject's bladder while implanted). The urethral implant 100 is configured and operative to apply continuous pressure, thereby expanding the internal cross-section at the stricture and increasing the flow capacity of urine through the urethra. While the urethral implant 100 is implanted, the drug delivery wire 106 is configured to release a drug at the implantation site at a controlled rate. The urethral implant 100 is removable from the urethra (by an implant removal mechanism (not shown)).

[0029] Reference is now made to Figure 2, which is a schematic illustration of a urethral implant having twisted wires shown in an expanded configuration, constructed and operative in accordance with another embodiment of the disclosed technology, generally designated by the numeral 150. The urethral implant 150 is generally similar in structure and function to the urethral implant 100 of Figures 1A-1C, except that the urethral implant 150 includes two twisted or intertwined wires (i.e., a pair of twisted wires) instead of only one wire as compared to the urethral implant 100.

[0030] Specifically, the urethral implant 150 includes two wires 152. 1 , 152 2 , a retainer 154, a drug delivery wire 156, and a proximal cap 162. In an alternative configuration (not shown), the proximal cap 162 is optional. 1 and 152 2 are joined together (helically twisted or intertwined) and each wire 152 1 and 1522 The urethral implant 150 includes two struts that extend longitudinally generally along a longitudinal axis 161L of the urethral implant 150 along a proximal portion 160A (interchangeably referred to herein as the "proximal end"), a central portion 160B (interchangeably referred to herein as the "middle portion"), and a distal portion 160C (interchangeably referred to herein as the "distal end"). 1 The two supports are 152 1 A and 152 1 B, wire 152 2 The two supports are 152 2 A and 152 2 B. Includes wire 152 1 Support material 152 1 A and 152 2 B is continuous (i.e., made from a single piece of wire) and converges at proximal end 160A. Similarly, wire 152 2 Support material 152 2 A and 152 2 B is continuous (i.e., made from a single piece of wire) and converges at proximal end 160A. In an alternative configuration (not shown), wire 152 1 152 of 1 A and 152 1 B are separate pieces that are mechanically joined together at distal end 160C and converge at proximal end 160A. In a similar alternative configuration (not shown), wire 152 2 Support material 152 2 A and 152 2 Wire 152 is a wire 152 having a central portion 160B that is mechanically joined to one another at distal end 160C and that converges at proximal end 160A. A central portion 160B is defined between proximal end 160A and distal end 160C. 1 and 152 2 is similar in function to the wire 102 of the urethral implant 100. Similarly, the anchor 154 and proximal cap 162 are similar in structure and function to the anchor 104 and proximal cap 112 (respectively) of the urethral implant 100 (FIGS. 1A-1C).

[0031] The urethral implant 150 is compressible between an expanded configuration and a compressed configuration (similar to the urethral implant 100). 1 and 152 2 Generally, the wires 152 have the same structural characteristics (e.g., equal length, thickness, cross-section) as well as the same material characteristics (e.g., are made of the same material and have the same mechanical properties such as elasticity, strength, malleability, resilience, etc.). In an alternative configuration (not shown), the wires 152 1 and 152 2 The wires 152 differ with respect to at least one attribute, such as structurally, geometrically (e.g., length, thickness, curvature), and materially different (i.e., not made of the exact same material or have different mechanical properties such as flexibility, strength, etc.). 1 and 152 2 is typically made of a medical grade biocompatible material (similar to wire 102).

[0032] The anchor 154 is identical to the anchor 104 of FIGS. 1A-1C. The anchor is a continuous wire structure including two sides embodied as two struts 154A and 154B, which extend outwardly from a proximal end 160A to a central portion 160B to one side of the longitudinal axis 161L of the urethral implant 150. The struts 154A and 154B are generally made from a single continuous piece of wire that converges at the proximal end 160A. Alternatively, the struts 154A and 154B are separate pieces (not shown) that are mechanically joined together at the apex (i.e., the tip of the anchor 154). The anchor 154 is flexible between an expanded configuration and a compressed configuration. The anchor 154 has the ability to self-expand to an expanded configuration when released from a delivery sheath (e.g., the sheath 114 of FIG. 1C). The fastener 154 is generally arcuate with an internal bore and two struts defining a symmetric closed shape (e.g., a closed loop). The fastener 154 is constructed and operative to engage and attach (anchor) to urethral tissue of a subject in an expanded configuration. The fastener 154 can be removed from the tissue once the urethral implant 150 is removed from the subject. The fastener 154 is secured to the wire 152. 1 and 152 2 Alternatively, the fixture 154 may be made of the same material as the fixture 152.1 and 152 2 It is not made of exactly the same materials.

[0033] Drug delivery wire 156 is similar in structure, composition and function to drug delivery wire 106 of FIGS. 1A-1C. 1 Support material 152 1 A and 152 1 B, and wire 152 2 Support material 152 2 A and 152 2 Along the length of B, wire 152 1 and 152 2 The drug delivery wires 156 are joined (e.g., continuously helically wrapped) to the wire 152 by helically wrapping them circumferentially along their entire length. The drug delivery wires 156 begin and end at the proximal end 160A (i.e., both ends terminate at the proximal end 160A). The drug delivery wires 156 are joined (e.g., continuously helically wrapped) to the wire 152 by helically wrapping them circumferentially along their entire length. 1 and 152 2 An alternative bond configuration between the drug delivery wire 156 and the closed-form wires is a parallel bond (i.e., the wires run parallel to one another, i.e., non-helical). The drug delivery wire 156 has an overall length that is parallel to each of the wires 152. 1 and 152 2 and according to one configuration, the length of the connected wire 152 1 and 152 2 According to another configuration (not shown), the drug delivery wire 156 may be arranged such that its entire length is shorter than the length of the associated wire 152. 1 and 152 2The drug delivery wire 156 may be tightly spirally wound to a length greater than the length of the urethral implant 150. The drug delivery wire 156 incorporates the same drug as the drug delivery wire 106. The drug functions to be distributed (i.e., released) into the urethra when the urethral implant 150 is implanted within a subject. When the drug delivery wire 156 is implanted, the drug is configured to gradually dissolve at a controlled rate according to its characteristic time-release drug profile. The drug delivery wire 156 is made of a single strand or multiple strands of a material (e.g., fibrous) that can absorb and exude the incorporated drug when the urethral implant 150 is implanted. The drug delivery wire 156 is compressible between a compressed configuration and an expanded configuration of the urethral implant 150.

[0034] When implanted in a subject, the urethral implant 150 facilitates dilating strictures in the subject's urethra by exerting pressure on the surrounding tissue. The urethral implant 150 includes two wires 152 (as opposed to the single wire of the urethral implant 100). 1 and 152 2 urethral implant 150 has a compression ratio of 0.1 to 0.2, which allows it to apply a greater force (pressure) per area to the surrounding tissue than urethral implant 100. When compressed, urethral implant 150 can store more mechanical energy than urethral implant 100. Urethral implant 150 is compressible between the extremes of a fully compressed configuration and a fully expanded configuration, with a continuum of intermediate compressed states between these extremes being possible.

[0035] The urethral implant 150 includes a wire 152 1 and 152 2 152 provides a synergistic effect between the mechanical action of the wire 152 and the therapeutic action of the drug delivery wire 156 that extends along the wire-tissue engagement region. 1 and 152 2 The wire 152 mechanically engages and applies pressure to the urethral tissue at the wire-tissue engagement region, while the drug delivery wire 156 simultaneously presses against the wire 152. 1 and 152 2and delivers the drug to the same urethral tissues (i.e., targeted drug delivery).

[0036] Reference is now made to Figures 3A, 3B and 3C. Figure 3A is a schematic illustration of a urethral implant shown in an expanded configuration, generally designated 200, constructed and operative in accordance with a further embodiment of the disclosed technology. Figure 3B is a schematic illustration of the urethral implant of Figure 3A including a proximal cap, constructed and operative in accordance with an embodiment of the disclosed technology. Figure 3C is a schematic illustration of the urethral implant of Figure 3B shown from a distal / proximal direction A, constructed and operative in accordance with an embodiment of the disclosed technology.

[0037] The urethral implant 200 is generally constructed from a wireframe structure that includes three categories of closed-shaped substructures with different shapes and functions. The first category of substructures is the mechanical structural framework of the urethral implant 200 that includes three closed shapes for engaging with the urethral tissue, dissecting the urethral tissue, and expanding the urethral tissue at the specific urethral location where the stricture occurs (i.e., the stricture). The second category of substructures is a fastener that includes at least one closed-shaped structure for engaging with the urethral tissue and fixing the urethral implant 200 in place. The third category of substructures includes at least one drug delivery wire that is loaded with a drug for delivery into the subject's urethra. The urethral implant 200 defines a proximal portion 210A, a middle portion 210B, and a distal portion 210C.

[0038] Specifically, the urethral implant 200 includes three closed-shape wires 202A, 202B, and 202C (i.e., a first category of substructures that are wire frame structures), a fastener 204 (i.e., a second category of substructures), and a drug delivery wire 206 (i.e., a third category of substructures), as shown in Figures 3A-3C. According to another configuration, the urethral implant 200 includes a proximal cap 212 at the proximal end 210A, as shown in Figures 3B and 3C. According to a minimum configuration shown in Figure 3A, the proximal cap 212 is not present (i.e., is optional).

[0039] Each closed-shaped wire includes two longitudinal portions extending between the proximal end 210A and the distal end 210C. Each closed-shaped wire may include a lateral portion between the two longitudinal portions. Specifically, the closed-shaped wire 202A includes a longitudinal portion 202A. 1 and 202A 2 and the longitudinal portion 202A 1 and 202A 2 The closed-shape wire 202B includes a longitudinal portion 202B and a lateral portion 203A connecting the longitudinal portion 202B and the lateral portion 203A (as shown in FIG. 3C). 1 and 202B 2 and the longitudinal portion 202B 1 and 202B 2 The closed-shape wire 202C includes a longitudinal portion 202C and a lateral portion 203B connecting the longitudinal portion 202C and the lateral portion 203B (as shown in FIG. 3C). 1 and 202C 2 and the long part 202C 1 and 202C 2 3C, and a lateral portion 203C connecting between the longitudinal portions 202A and 203B (as shown in FIG. 3C). Each longitudinal portion of the closed-shaped wire is joined along its length to another longitudinal portion of another closed-shaped wire. Specifically, the longitudinal portion 202A of the closed-shaped wire 202A 2 The longitudinal portion 202B of the closed shaped wire 202B along its length 1 and the long portion 202B of the closed-shaped wire 202B is joined to 2 The longitudinal portion 202C of the closed shaped wire 202C along its length 1 2, and the long portion 202A of the closed-shaped wire 202A is joined to the 1 The longitudinal portion 202C of the closed shaped wire 202C along its length 2According to a preferred configuration, each closed shape is composed of a single continuous wire defining at least two longitudinal portions. Alternatively, there are three portions (lateral portions between the two longitudinal portions). As shown in Figures 3A to 3C, the method of joining the wires is as a twisted or intertwined pair of wires, twisting one around the other (longitudinal portion) in a helical manner, with one wire twisted clockwise and the other twisted counterclockwise (left hand / right hand winding). In a preferred configuration, the wires are composed of the same material and have the same physical attributes (e.g., width, cross section). In an alternative configuration (not shown), the wires are not the same in at least one respect (e.g., composition, physical attributes, etc.).

[0040] With particular reference to FIG. 3C, the urethral implant 200 forms a triangular pyramidal structure with a triangular base formed from the lateral portions 203A, 203B, and 203C of the distal end 210C and an apex at the proximal end 210A where the longitudinal wires converge (at the proximal cap 212 in FIG. 3B and FIG. 3C, and without the proximal cap in FIG. 3A). The proximal cap 212 covers the ends of the first, second, and third categories of wires with the proximal portion 210A as shown in FIG. 3B. Specifically, the proximal cap 112 covers the ends of the wires 202A, 202B, 202C, the ends of the anchor 204, and the ends of the drug delivery wire 206 with the proximal portion 210A (FIG. 3B). In an alternative configuration (not shown), the wires 202A, 202B, and 202C are closed curves (i.e., have no end points).

[0041] The fastener 204 is identical to the fastener 104 of Figures 1A-1C and the fastener 154 of Figure 2. The fastener 204 is a continuous wire structure with two sides embodied as two struts 204A and 204B, which extend outwardly to one side of the urethral implant 200 from a proximal end 210A to a central portion 210B and terminate at a terminal portion (i.e., the tip, apex of the fastener 204). The fastener 204 generally starts at the proximal end 210A and passes through one of the closed shape wires (e.g., the closed shape wire 202B as shown in Figures 3B and 3C). The struts 204A and 204B are generally made of a single continuous piece of wire that converges at two points, the starting point at the proximal end 210A and the terminal portion of the fastener 204. In an alternative configuration, the struts 204A and 204B are separate pieces (not shown) that are mechanically joined together at the apex or tip of the fastener. In another alternative configuration (not shown), the fastener 204 is a closed curve (i.e., has no end points). The fastener 204 is flexible between an expanded configuration and a compressed configuration. The fastener 204 has the ability to self-expand to an expanded configuration upon release from a delivery sheath (e.g., sheath 114 of FIG. 1C). The fastener 204 is generally arcuate with an internal hole and the two struts defining a symmetrical closed shape (e.g., a closed loop). When in the expanded configuration, the fastener 204 effectively expands the overall width of the urethral implant 200 by extending beyond the width of the closed shape wire. The fastener 204 is constructed and operative to engage and attach (anchor) to a target urethral tissue in the expanded configuration. The fasteners 204 can be removed from the tissue once the urethral implant 200 is removed from the subject. The fasteners 204 are made of the same material as the closed shaped wire. Alternatively, the fasteners 204 are not made of the exact same material that makes up the closed shaped wire.

[0042] The drug delivery wire 206 is similar in structure, composition and function to the drug delivery wire 106 of Figures 1A-1C and the drug delivery wire 156 of Figure 2. The drug delivery wire 206 is a closed configuration wire 202A having a wire length 202A. 1 and 202A 2 , the long portion 202B of the closed-shaped wire 202B 1 and 202B2 , as well as the longitudinal portion 202C of the closed-shaped wire 202C. 1 and 202C 2 3C, the drug distribution wire 206 is joined (i.e., helically wound and spliced ​​continuously) to the side portions 203A and 203B, but not along the length of the side portion 203C. In an alternative configuration (not shown), the drug distribution wire 206 is joined to the side portion 203C (i.e., spliced ​​to all of the longitudinal and lateral wires). The drug distribution wire 206 is continuous and begins and ends at the proximal end 210A (i.e., both ends terminate at the proximal end 210A). The drug distribution wire 206 is helically wound circumferentially along the entire length of the longitudinal portion of each closed-shaped wire. The manner in which the drug distribution wire 206 twists or intertwines around the longitudinal portion can be clockwise or counterclockwise (e.g., left or right). The overall length of the drug delivery wire 206 is greater than the length of each closed configuration wire. The drug delivery wire 206 is compressible between the compressed and expanded configurations of the urethral implant 200.

[0043] The drug delivery wire 206 is loaded with the same drug that is loaded into the drug delivery wire 106. The drug is distributed (i.e., released, administered) into the urethra when the urethral implant 200 is implanted into the subject. When the drug delivery wire 206 is implanted with the urethral implant 200, the drug gradually dissolves at a controlled rate according to its characteristic time-release drug profile. The drug comprises a chemical configured to produce or exert a biological effect on the subject. The drug delivery wire 206 is made of a single strand or multiple strands of a material (e.g., fibrous) that can absorb and exude the loaded drug when the urethral implant 200 is implanted.

[0044] Alternative configurations (not shown) of the drug delivery wire 206 include being joined (e.g., spirally wound) to only one longitudinal portion. Another alternative configuration includes having multiple drug delivery wires, each incorporating a different drug or the same drug. In the case of at least two different drug delivery wires, each wire incorporates a different drug with a different time release profile. Alternatively, the two drug delivery wires can incorporate the same drug but with different time release profiles (linear, non-linear, burst, etc.). The different drug delivery wires may also be constructed from different materials.

[0045] The urethral implant 200 (including the closed shaped wires 202A, 202B, and 202C, the anchor 204, and the drug delivery wire 206) is compressible between an expanded configuration and a compressed configuration (similar to the urethral implants 100 and 150). The closed shaped wires 202A, 202B, and 202C generally have the same structural characteristics (e.g., dimensions such as length, thickness, cross-section, etc.) as well as the same material characteristics (e.g., made of the same material and have the same mechanical properties such as elasticity, strength, malleability, resilience, etc.). In an alternative configuration (not shown), the wires 202A, 202B, and 202C differ with respect to at least one attribute, such as structurally, geometrically (e.g., length, thickness, curvature), and materially different (i.e., not made of the exact same material or have different mechanical properties such as flexibility, strength, etc.). Wires 202A, 202B and 202C are generally made of medical grade biocompatible materials (such as wires 102 and 152 of the previous embodiment). 1 and 152 2 It is made using the same method as above.

[0046] After the urethral implant 200 is implanted in a subject, the urethral implant 200 easily dilates strictures in the urethra by exerting pressure on the surrounding tissue. The double-entangled wires (pair of twisted wires) of the urethral implant 200 can store more mechanical energy when in a compressed state than the single-wire urethral implant 100. The urethral implant 200 is generally compressible between a fully compressed configuration and a fully expanded configuration, with continuous intermediate compressed states between the two extremes being possible. According to an alternative configuration (not shown), the urethral implant can include three or more entangled wires, such as a (e.g., longitudinal) wire bundle.

[0047] The urethral implant 200 provides a synergistic effect between the mechanical action of the closed wires 202A, 202B and 202C and the therapeutic action of the drug delivery wire 206 that extends along the wire-to-tissue engagement region. 1 , 202A 2 , 202B 1 , 202B 2 , 202C 1 and 202C 2 The wire 206 mechanically engages and applies pressure to the urethral tissue at the engagement area between the wire and the tissue, and at the same time, the drug distribution wire 206 contacts the same urethral tissue as the longitudinal portion of the closed configuration wire and delivers drug to those same tissues (i.e., targeted drug delivery).

[0048] Reference is now made to Fig. 4, which is a schematic illustration of a urethral implant having multiple discontinuous drug delivery wires shown in an expanded configuration, generally designated 250, constructed and operative in accordance with another embodiment of the disclosed technology. The urethral implant 250 is similar to the urethral implant 200 of Figs. 3A-3C, except for the drug delivery wire having multiple discontinuous portions. The urethral implant 250 defines a proximal portion 260A, a central portion 260B, and a distal portion 260C. Specifically, the urethral implant 250 includes three closed-shaped wires 252A, 252B, and 252C, a retainer 254, a proximal cap 262, and multiple drug delivery wires 256. 1 , 2562 , 256 3 , 256 4 , 256 5 , 256 6 and 256 7 Generally, the urethral implant 250 includes a plurality of drug delivery wires N 256. 1 From 256 N (N is a positive integer greater than 1). In particular, without loss of generality, urethral implant 250 includes (by way of example) seven separate, discontinuous drug delivery wires, each of different lengths, each coupled to at least a portion of one of closed-shaped wires 252A, 252B, and 252C. Specifically, drug delivery wire 256 1 is wire 252A 1 and 252C 2 256 coupled to a drug delivery wire 2 is wire 252A 1 and 252C 2 256, coupled to a drug delivery wire 3 is wire 252A 1 , 252C 2 , 252B 1 and 252A 2 256, coupled to a drug delivery wire 4 is wire 252A 1 , 252C 2 , 252B 2 and 252C 1 256 coupled to a drug delivery wire 5 is wire 252A 2 and 252B 1 256 coupled to a drug delivery wire 6 Wire 252B 2 and 252C 1 256, coupled to a drug delivery wire 7 is wire 252B 2 , 252C 1 , 252A 1 and 252C 2 In an alternative configuration (not shown) to that shown in FIG. 1 From 256 7 are equal in length. In one configuration, the drug delivery wires 256 1From 256 7 are the same and have the same properties, i.e., incorporate the same drug composition and the same drug time release profile, physical attributes (e.g., length, width, cross-section, curvature, tortuosity, etc.). 1 From 256 7 At least one of the drug delivery wires differs from the other drug delivery wires in at least one characteristic, such as drug composition, drug time release profile, mechanism of action (MOA), physical attribute, etc. 1 is loaded with the drug sirolimus and drug delivery wire 256 3 incorporates the drug everolimus. In general, different combinations of different properties are possible for different drug delivery wires.

[0049] The closed shape wires 252A, 252B, and 252C, the fastener 254, and the proximal cap 262 are similar in structure and function to the closed shape wires 202A, 202B, and 202C, the fastener 204, and the proximal cap 212 (respectively) described in connection with Figures 3A-3C. The description of the elements in connection with Figures 3A-3C applies to the same elements of the urethral implant 250 in Figure 4.

[0050] Reference is now made to Fig. 5, which is a schematic illustration of a urethral implant, generally designated 300, having a drug delivery wire coupled to a closed-shape wire including a fastener, constructed and operative in accordance with a further embodiment of the disclosed technology. The urethral implant 300 is the same as the urethral implant 200 of Figs. 3A-3C, except for the additional drug delivery wire coupled to the fastener. Specifically, the urethral implant 300 includes three closed-shape wires 302A, 302B, and 302C, a fastener 304, a drug delivery wire 306, a drug delivery wire 308, and a proximal cap 312. The urethral implant 300 defines a proximal portion 310A, a central portion 310B, and a distal portion 310C. The fastener 304 is identical to the fastener 204 of Figs. 3A-3C. The anchor 304 is a continuous wire structure with two sides embodied as two struts 304A and 304B, which extend outwardly to one side of the urethral implant 300 from a proximal end 310A to a central portion 310B and terminate at a terminal end (i.e., the tip, apex of the anchor 304). The struts 304A and 304B are generally made of a single continuous piece of wire that converges at two points, namely the starting point at the proximal end 310A and the terminal end of the anchor 304. The anchor 304 is flexible between an expanded configuration and a compressed configuration. The anchor 304 has the ability to self-expand to an expanded configuration. The anchor 304 is generally arcuate with an inner hole and the two struts 304A and 304B define a symmetrical closed shape (e.g., a closed loop).

[0051] The drug delivery wire 308 is bonded (i.e., continuously helically wound and joined) to the struts 304A and 304B of the fastener 304. The drug delivery wire 308 and fastener 304 are compressible between a compressed configuration and an expanded configuration of the urethral implant 300. In one configuration, the drug delivery wire 308 is different from the drug delivery wire 306. The differences include different structure, composition, type of drug incorporated, time release profile of the drug, function, etc. For example, the drug delivery wire 308 is composed of thinner and shorter fibers or fiber strands than those of the drug delivery wire 306, as shown in FIG. 5. Also, the drug delivery wire 308 can incorporate a different drug than the drug delivery wire 306, such as non-steroidal anti-inflammatory drugs (NSAIDS). In another alternative configuration (not shown), the drug delivery wire 308 is the same as the drug delivery wire 306 in structure, composition, function, etc. In another alternative configuration (not shown), each of the struts 304A and 304B has a different drug delivery wire coupled to it, in such a configuration, the difference between them may be manifested by at least one differentiating characteristic (e.g., with respect to structure, composition, drug incorporated, mechanism of action (MOA), etc.).

[0052] The closed shape wires 302A, 302B, and 302C, the fastener 304, the drug delivery wire 306, and the proximal cap 312 are similar in structure and function to the closed shape wires 202A, 202B, and 202C, the fastener 204, and the proximal cap 212 (respectively) described in connection with Figures 3A-3C. The description of the elements in connection with Figures 3A-3C applies to the same elements of the urethral implant 300 of Figure 5.

[0053] Reference is now made to Figures 6A, 6B, 6C and 6D, which are schematic illustrations of various configurations of drug delivery wires constructed and operative in accordance with embodiments of the disclosed technology. The wires and drug delivery wires of the urethral implant wire frame structures described below in connection with Figures 6A-6D are identical to the wires and drug delivery wires of the urethral implant wire frame structures previously described in the previous embodiments in connection with Figures 3A-3C, 4 and 5.

[0054] 6A is a schematic diagram illustrating a double helix configuration of two drug delivery wires helically wound around two wires of a urethral implant of the disclosed technology, generally designated 400. Specifically, FIG. 6A illustrates two urethral implant wires 402. 1 and 402 2 and two drug delivery wires 406 1 and 406 2 4A and 4B are shown (only partially shown, i.e., not their entire length). In particular, the drug delivery wire 406 1 and 406 2 402 wire 1 and 402 2 The drug delivery wire 406 is embodied as two helices in a double helix configuration helically wrapped around (i.e., joined with) the drug delivery wire 406. 1 and 406 2 are the same or congruent (translated or wire 402 1 and 402 2 Alternatively, the drug delivery wire 406 may be a tubular drug delivery wire that is tubular and has a diameter that is greater than or equal to 100 mm (i.e., they have the same geometry, composition, and incorporate the same drug). 1 and 406 2 differ in at least one respect (eg, are structurally different, incorporate different drugs, are composed of different materials, have different time release profiles, etc.).

[0055] 6B is a schematic diagram illustrating a three-strand braided configuration including three drug delivery wires for wrapping around two wires of a urethral implant of the disclosed technology, generally designated 420. Specifically, FIG. 6B illustrates three drug delivery wires 426 for wrapping around a wire frame structure (not shown) of a urethral implant of the disclosed technology. 1 , 426 2 and 426 3 4. In one configuration, the drug delivery wire 426 1 , 426 2 and 426 3are identical (i.e., they have the same geometry, composition, and incorporate the same drug) (different only in their translation or position along the wire). Alternatively, at least one drug delivery wire 426 1 , 426 2 and 426 3 differs in at least one respect from at least one other drug delivery wire (eg, is structurally different, has a different drug embedded therein, is composed of a different material, has a different time release profile, etc.).

[0056] FIG. 6C is a schematic diagram illustrating a drug delivery fabric configuration, generally designated 440, covering two wires of a urethral implant of the disclosed technology. Specifically, FIG. 6C illustrates a urethral implant wire 442. 1 and 442 2 3A and a drug-distribution fabric 446 (only partially shown, i.e., not their entire length) covering the wire. Drug-distribution fabric 446 is incorporated with drugs according to the principles previously described (e.g., drug-distribution wire 306). Fabric 446 can be a woven or non-woven fabric (e.g., glued together). According to one configuration, drug-distribution fabric 446 is a fabric (e.g., cotton, polyester) with a drug incorporated therein that can be distributed when implanted in a subject's body. According to an alternative configuration, fabric 446 is a material other than a fabric (e.g., a polymer) woven in a pattern. Multiple materials can be woven in various patterns (e.g., plain weave, etc.).

[0057] FIG. 6D is a schematic diagram illustrating two different drug delivery wire configurations for the two wires of the urethral implant of the disclosed technology, generally designated 460. Specifically, FIG. 6D illustrates the configuration of urethral implant wire 462. 1 and 462 2 and three drug delivery wire groups. The first drug delivery wire group is wire 462 1 4, a drug delivery wire 466 connected to and extending parallel to the 1 The second group of drug delivery wires includes wire 462.2 Partially along the length of the wire 462 2 462 is connected to the wire 2 A plurality of separate drug delivery wires 466 extending perpendicular to the direction of extension of the 2 The third drug delivery wire group includes wire 462. 2 Partially along the length of the wire 462 2 462 is connected to the wire 2 A plurality of separate drug delivery wires 466 extending in an X-pattern or cross pattern along the extension direction of the 3 Alternative configurations (not shown) are possible (e.g., diagonal pattern, O pattern, V pattern, etc.).

[0058] It will be appreciated by persons skilled in the art that the disclosed technology is not limited to what has been particularly shown and described above. [Explanation of symbols]

[0059] 100 Urethral Implants 101L Longitudinal axis 102 Tissue Engagement Wire 102A, 102B Struts 104 Tissue Engaging Fixtures 104A, 104B Struts 106 Drug Delivery Wire 110A Proximal 110B Central part 110C Distal part 112 Proximal Cap 114 Delivery sheath 150 Urethral Implants 152 1 , 152 2 Wire 152 1 A, 152 1 B, 152 2 A, 152 2 B Strut 154 Fixtures 154A, 154B Struts 156 Drug Delivery Wire 160A Proximal 160B central part 160C distal section 161L Longitudinal axis 162 Proximal Cap 200 Urethral Implants 202A, 202B, 202C Closed Wire 202A 1 , 202A 2 , 202B 1 , 202B 2 , 202C 1 , 202C 2 Longer part 203A, 203B, 203C side part 204 Fixtures 204A, 204B Struts 206 Drug Delivery Wire 210A Proximal 210B Central part 210C Distal part 212 Proximal Cap 250 Urethral Implant 252A, 252B, 252C Closed Wire 254 Fixtures 256 1 , 256 2 , 256 3 , 256 4 , 256 5 , 256 6 , 256 7 Drug Delivery Wire 260A Proximal 260B Central part 260C Distal part 262 Proximal Cap 300 Urethral Implant 302A, 302B, 302C Closed Shape Wire 304 Fixtures 304A, 304B Struts 306, 308 Drug delivery wire 310A Proximal 310B Central part 310C Distal part 312 Proximal Cap 400 double helix configuration 402 1 and 402 2 Urethral implant wire 406 1 and 406 2 Drug delivery wire 420 Three-strand braided structure 426 1 and 426 2 and 426 3 Drug delivery wire 440 Drug delivery fabric structure 442 1 and 442 2 Urethral implant wire 446 Drug delivery fabric 466 1 and 466 2 and 466 3 Drug delivery wire

Claims

1. 1. A urethral implant comprising: at least two struts extending longitudinally between a proximal end and a distal end of the urethral implant; a fastener extending outwardly from at least one of the proximal end and the distal end for fastening the urethral implant to the urethra; at least one drug delivery wire joined to and extending longitudinally along at least one of the struts, the drug delivery wire incorporating a drug for release into the urethra; Each of the at least two struts comprises: A urethral implant that is flexible between a compressed configuration that allows the urethral implant to be delivered to a stricture in the urethra and an expanded configuration that facilitates dilation of the stricture.

2. 10. The urethral implant of claim 1, wherein each of the at least two struts, the anchor, and the at least one drug delivery wire is a continuous wire.

3. a proximal cap disposed at the proximal end; 3. The urethral implant of claim 2, wherein the proximal cap is configured to cover an end of each of the continuous wires of the at least two struts, the fasteners and the at least one drug delivery wire.

4. The urethral implant of claim 1 , configured to apply pressure to tissue of the urethra.

5. 10. The urethral implant of claim 1, wherein said at least one drug delivery wire is loaded with said drug selected from the list consisting of sirolimus (rapamycin) and everolimus.

6. 10. The urethral implant of claim 1, wherein the at least one drug delivery wire is helically wrapped around at least one of the struts.

7. The urethral implant of claim 1 , wherein the at least one drug delivery wire comprises a plurality of drug delivery wires, each drug delivery wire being loaded with a different drug.

8. 10. The urethral implant of claim 1, wherein the at least one drug delivery wire is made of at least a single strand of a material configured to absorb and exude the drug.

9. 10. The urethral implant of claim 1, wherein the at least one drug delivery wire is configured to dissolve at a controlled rate according to its characteristic time release profile after the urethral implant is implanted in the urethra.

10. The urethral implant of claim 1 , wherein each of the at least two struts comprises a pair of twisted wires extending longitudinally between the proximal and distal ends.

11. The urethral implant of claim 1 , wherein in the compressed configuration, the implant is configured to be contained within a sheath.

12. The urethral implant of claim 1 , configured to be implanted in the urethra and to apply pressure to tissue surrounding the urethra in the expanded configuration.

13. The urethral implant of claim 1 , wherein the fastener is configured to prevent the urethral implant from migrating toward the bladder.

14. The urethral implant of claim 1 , having an intermediate compressed state between the expanded configuration and the compressed configuration.

15. The urethral implant of claim 1 , which is removable from the urethra.

16. 1. A urethral implant comprising: three closed configuration wires that are flexible between a compressed configuration that allows the urethral implant to be delivered to a stricture in the urethra and an expanded configuration that facilitates dilation of the stricture; a fastener extending outwardly from at least one of a proximal end and a distal end of the urethral implant for securing the urethral implant to the urethra; at least one drug delivery wire joined to and extending longitudinally along at least one of the closed shaped wires, the drug delivery wire incorporating a drug for release into the urethra; A urethral implant, wherein each of the three closed shaped wires includes two longitudinal portions extending between the proximal end and the distal end, and each longitudinal portion of the closed shaped wire is joined along its length to another longitudinal portion of another of the closed shaped wires.

17. 17. The urethral implant of claim 16, wherein each of the three closed-shape wires, the fastener, and the at least one drug delivery wire are each a continuous wire.

18. a proximal cap disposed at the proximal end; 20. The urethral implant of claim 17, wherein the proximal cap is configured to cover an end of each of the three closed shape wires, the anchor and the at least one drug delivery wire.

19. The urethral implant of claim 16 , configured to apply pressure to tissue of the urethra.

20. 17. The urethral implant of claim 16, wherein the at least one drug delivery wire is loaded with the drug selected from the list consisting of sirolimus (rapamycin) and everolimus.

21. 17. The urethral implant of claim 16, wherein the at least one drug delivery wire is helically wrapped around at least one of the three closed-shape wires.

22. 17. The urethral implant of claim 16, wherein the at least one drug delivery wire comprises a plurality of drug delivery wires, each drug delivery wire being loaded with a different drug.

23. 17. The urethral implant of claim 16, wherein the at least one drug delivery wire is made of at least a single strand of a material configured to absorb and exude the drug.

24. 17. The urethral implant of claim 16, wherein the at least one drug delivery wire is configured to dissolve at a controlled rate according to its characteristic time release profile after the urethral implant is implanted in the urethra.

25. The urethral implant of claim 16 , wherein in the compressed configuration, the implant is configured to be contained within a sheath.

26. 17. The urethral implant of claim 16, configured to be implanted in the urethra and to apply pressure to tissue surrounding the urethra in the expanded configuration.

27. 17. The urethral implant of claim 16, wherein the fastener is configured to prevent the urethral implant from migrating toward the bladder.

28. 17. The urethral implant of claim 16, having an intermediate compressed state between the expanded configuration and the compressed configuration.

29. The urethral implant of claim 16, which is removable from the urethra.

30. 17. The urethral implant of claim 16, wherein the at least one drug delivery wire comprises at least two drug delivery wires, at least one of the drug delivery wires being joined to at least one of the three closed shape wires, and at least another of the drug delivery wires being joined to the fastener.

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